The regulatory landscape continues to change. One of the quality system approaches defined by regulators and the industry for mitigating risk is corrective and preventive action, better known as CAPA. Companies are often challenged by the CAPA process, which is one of the most important and essential elements of a quality management system within the regulated medical device industry. A CAPA program, effectively implemented and integrated, can affect all areas of an organization, including production and process control, design, purchasing, and more. An inadequate execution of a CAPA strategy continues to be one of the most common nonconformities cited during audits and inspections within highly regulated environments.

To develop an effective and robust CAPA system and management process, it is important to oversee compliance and analyze relevant metrics and measurements. An understanding of the regulatory requirements of certain countries, depending on the nature of your organization and supply chain, is also critical. All of this must be integrated into the system.

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